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Background: Deep vein thrombosis (DVT) is a common cardiovascular emergency that may have life-threatening complications,including pulmonary embolism (PE) and post-thrombotic syndrome (PTS).Conventional anticoagulant medication does not completely dissolve the clots and does not decrease the risk of DVT complications,lnvasive catheter-directed thrombolysis (CDT) is an approach that has been reported to reduce the reoccurrence of PTS during acute DVT.We compared balloon-assisted CDT with routine CDT in the treatment of acute DVT and evaluated the clinical efficacy and safety of balloon-assisted CDT.Methods: This retrospective cohort study included 94 patients diagnosed with a first episode of DVT in the lower extremities and treated from September 2008 to February 2018.The patients underwent routine CDT (group A,n =50) or balloon-assisted CDT (group B,n =44) based on their enrollment date.We obtained the circumference difference between the limbs,the degree of clot lysis,and the lysis rate as parameters for evaluating the two approaches.The PE incidence and bleeding amount were recorded.We also compared the total urokinase dose,treatment duration,and retrieval rate of optional filters.Results: Swelling was significantly alleviated in both groups,as indicated by a reduction in the limb circumference.Patients who underwent balloon-assisted CDT exhibited significantly lower thrombus scores compared with the routine group (S =1403.50,Z =-5.7702,P ＜ 0.0001).Additionally,the duration of balloon-assisted CDT was significantly shorter (6 vs.10 days[S =1039.0,Z =-8.0358,P ＜ 0.0001]).The mean urokinase usage per patient was decreased in the balloon-assisted group (P ＜ 0.0001).Bleeding occurred in both groups,with no statistical significance.The filter retrieval rate in the balloon-assisted group was significantly higher than that in the routine CDT group (X2 =4.829,P =0.028).Conclusions: Balloon-assisted CDT is an effective,cost-efficient,and safe method for the treatment of acute DVT.It exhibited advantages over routine CDT,including less lysis medication,decreased procedure duration,and higher patency rates.Inferior vena cava filtration is mandatory in balloon-assisted CDT.After thrombus removal,the risk of symptomatic PE did not increase in this approach.